Regulatory PathRegulatory requirements compared

Active substance

Sucralfate

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
GASTROFAIT TAB 500MG500 mgTablet · Oral use20 BlisterSAR 11.80NCE · PrescriptionEIPICOValid
ULCICURE TAB 1 GM1 gTablet · Oral use30 BlisterSAR 11.25Generic · PrescriptionALAMRIAH FOR PHARMACEUTICALS INDUSTRIESWithdrawn by MAH · Not Marketed
ULSAHEAL 1000 SUSP (1000MG-5ML)200 mg/mlOral suspension · Oral use1 BottleSAR 26.50NCE · PrescriptionHikma Pharmaceuticals PLCWithdrawn by MAH · Not Marketed
ULSAHEAL TAB 1G1 gTablet · Oral use50 BlisterSAR 20.80Generic · PrescriptionHikma Pharmaceuticals PLCWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

DYSPEPSIA; GASTROESOPHAGEAL REFLUX DISEASE (GERD)

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
CARAFATE1GMtablet · oralABBVIEPrescription30 Oct 1981
SUCRALFATE1GMtablet · oralTEVAPrescription29 Mar 1996
SUCRALFATE1GMtablet · oralCHARTWELL RXPrescription8 Jun 1998
SUCRALFATE1GM/10MLsuspension · oralAMNEALPrescription2 Dec 2019
SUCRALFATE1GM/10MLsuspension · oralVISTAPHARM LLCPrescription15 Mar 2022
SUCRALFATE1GMtablet · oralAMNEAL PHARMSPrescription15 Apr 2022
SUCRALFATE1GM/10MLsuspension · oralMYLANPrescription12 Sep 2022
SUCRALFATE1GMtablet · oralZYDUS LIFESCIENCESPrescription3 May 2023
SUCRALFATE1GM/10MLsuspension · oralPD PARTNERSPrescription17 Jan 2024
SUCRALFATE1GM/10MLsuspension · oralABON PHARMS LLCPrescription21 Mar 2024
SUCRALFATE1GM/10MLsuspension · oralSTRIDES PHARMAPrescription21 May 2024
SUCRALFATE1GM/10MLsuspension · oralCOSETTE PHARMS NCPrescription13 Nov 2024
SUCRALFATE1GM/10MLsuspension · oralCHARTWELL RXPrescription14 Apr 2025
SUCRALFATE1GM/10MLsuspension · oralGLENMARK PHARMS LTDPrescription5 Jan 2026
CARAFATE1GM/10ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**suspension · oralABBVIEDiscontinued16 Dec 1993
SUCRALFATE1GM/10MLsuspension · oralHIKMA PHARMSDiscontinued23 Jul 2024

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
AA-SUCRALFATE021252501 GTABLET · ORALAA PHARMA INC
SULCRATE021006221 GTABLET · ORALABBVIE CORPORATION
SULCRATE SUSPENSION PLUS021035671 G / 5 MLSUSPENSION · ORALABBVIE CORPORATION
TEVA-SUCRALFATE020457021 GTABLET · ORALTEVA CANADA LIMITED

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACCARAFATE 1 GM TABLET$4.73077per EA23 Sep 2026
US NADACSUCRALFATE 1 GM TABLET$0.1727per EA23 Sep 2026
US NADACSUCRALFATE 1 GM/10 ML SUSP$0.12412per ML23 Sep 2026
US NADACSUCRALFATE 1 GM/10 ML SUSP$0.13714per ML23 Sep 2026
US NADACSUCRALFATE 1 GM/10 ML SUSP$0.11631per ML23 Sep 2026
NHS Drug TariffSucralfate 1g/5ml oral suspension sugar free£288.48200 ml1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

All safety entries for sucralfate →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.